Fixation assembly with a flexible elongated member for securing parts of a sternum

ABSTRACT

A fixation assembly for securing parts of a sternum is provided. The assembly comprises a flexible elongated member and an attachment member. The flexible elongated member includes a locking structure configured to secure the flexible elongated member in a loop around the sternum parts. The attachment member has at least one opening for receiving a bone fastener and is coupled to the flexible elongated member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/895,163, filed on Dec. 1, 2015, which is a national phase entry under35 U.S.C. § 371 of International Application No. PCT/EP2013/066408 filedAug. 5, 2013, published in English, which claims priority from U.S.Provisional Patent Application No. 61/845,024 filed Jul. 11, 2013, allof which are incorporated herein by reference.

TECHNICAL FIELD

The present disclosure generally relates to sternal fixation.Specifically, the disclosure relates to a fixation assembly for securingparts of a sternum and to a system compromising the fixation assembly.

BACKGROUND OF THE INVENTION

Various surgical procedures require the surgeon to access the thoracicregion of a patient. A known procedure to access the thoracic region isto cut the sternum in two parts and separate these two parts from eachother. After completion of the surgical procedure, the separated partsof the sternum are brought back to their initial position and fixed, forexample, with a bone plate attached to the sternum parts or a wiretensioned around the circumference of the sternum.

EP 0 597 259 A2 discloses a wound closure element to be looped around ahuman sternum. The wound closure element comprises a strap which isinserted through and retained by a tightening plate.

U.S. Pat. No. 8,460,295 B2 discloses a sternum repair device including acentral body and plurality of bands extending from the central body. Thebands may wrap around the sternum to keep the separate sternum partstogether. The central body includes a view window which is used by asurgeon to line up the device during installation on the sternum.

WO 2010/042946 A1 discloses a cerclage system including a cable thatencircles the sternum parts and a bone plate having channels to receivesegments of the cable. The bone plate further includes a pair of lockingstuds to lock the cable within the channels to the bone plate.

EP 0 608 592 B1 discloses an assembly for banding a sternum. Theassembly comprises an elongated flexible band, a needle at one end ofthe band and a buckle proximate the other end of the band. A mainsection of the band includes a plurality of spaced slots which canengage at a locking mechanism.

After a surgical procedure such as, for example, a bypass operation hasbeen carried out on a patient and the sternum has been closed using anyof the known fixation assemblies, the patient is normally kept undersurveillance. If it is detected that the surgical procedure has failedin any manner, it may be desirable for the surgeon to again open thesternum closure. The time required for this sternum opening proceduremay be critical for the patient's health and even life. Moreover, acable or wire tensioned around the sternum parts (so-called “primaryclosure”) might come loose or brake due to the load applied to thethoracic region of the patient. In such a case, the fixation has to bestabilized by, for example, a bone plate (so-called “secondary closure”)

BRIEF SUMMARY OF THE INVENTION

There is a need for a fixation assembly for securing parts of a sternumthat can be attached or separated fast, easily and at low risk for thepatient. Furthermore, there is a need for a fixation assembly whichprovides a high assembly-sternum-construct-stability. Moreover, there isa need for a fixation assembly for securing parts of a sternum thatexhibits good surgical results.

Further aspects of the present disclosure are directed to the provisionof a fixation assembly and fixation systems that facilitate a rapidhealing of a sternum and guarantee a stable configuration of both thefixation system and the sternum parts.

According to one aspect, there is provided a fixation assembly forsecuring parts of a sternum. The fixation assembly comprises a flexibleelongated member and an attachment member. The flexible elongated memberincludes a locking structure configured to secure the flexible elongatedmember in a loop around the sternum parts. The attachment member has atleast one opening for receiving a bone fastener and the attachmentmember is coupled to the flexible elongated member.

The attachment member may be formed as an insert in the flexibleelongated member. In one realization, the attachment member can be castin the flexible elongated member. Alternatively, or in addition, theflexible elongated member may have a receiving structure configured toreceive the attachment member. The attachment member can be held in thereceiving structure by a form fit. For example, the form fit may berealized by a snap fit. The receiving structure may be configured toestablish the holding of the attachment member by a snap fit. This maybe accomplished with a flexible or elastic protrusion of the receivingstructure.

Further, the receiving structure may include at least one opening. Theat least one opening of the receiving structure may substantiallyoverlap with the at least one opening of the attachment member. At leasta part of the receiving structure may have a thickness which is largerthan or substantially equal to a thickness of the flexible elongatedmember.

In one implementation, the attachment member may include a guidingstructure for slideably engaging the flexible elongated member. Theguiding structure of the attachment member may be formed as a recess oran opening. The recess or the opening may slideably receive the flexibleelongated member. The recess or the opening may have a shape adapted toguide the flexible elongated member in at least one direction.

The attachment member may be adapted to be slided onto the flexibleelongated member. Alternatively, or in addition, the attachment membermay be adapted to be clamped on the flexible elongated member.

In one realization, the at least one opening of the attachment membermay include a locking feature configured to lock a bone fastener to theattachment member. The locking feature may include a threaded portion orone or more lips in a circumferential direction adapted to engage a bonefastener (e.g., a threaded head thereof). Further, the locking featuremay engage a threaded head of a bone fastener at a selected angularorientation. The at least one opening of the attachment member may havea multiple thread (e.g., a double thread). Further, the at least oneopening of the attachment member may comprise a threaded portion on abone contacting side of the attachment member and an unthreaded portionon a side opposite to the bone contacting side.

The at least one opening of the attachment member may have a conical,convex or spherical taper which substantially tapers inwardly in adirection toward a bone contacting surface of the attachment member.Thus, at least one opening of the attachment member can be configured toexert a force on the attachment member when a bone fastener is screwedor inserted through the opening into the sternum.

In one implementation, the at least one opening of the attachment membermay have an inclined surface onto which a bone fastener is able to slidein a fastening or compression position. The at least one opening of theattachment member may permit a bone fastener to slide laterally orlongitudinally with respect to the opening or the attachment member.Further, at least one opening of the attachment member may define apredetermined direction for a bone fastener. The inclined surface mayhave a predetermined angle with respect to an extension plane of theattachment member. The predetermined angle can be between about 20 and70 degrees, for example about 40 to 50 degrees (e.g., about 45 degrees).

The at least one opening of the attachment member may be a circular orelongated hole. The elongated hole may be an oblong hole. Further, theelongated hole may extend substantially parallel with respect to alongitudinal direction of the attachment member or of the flexibleelongated member. Alternatively, the elongated hole may extendsubstantially perpendicular to a longitudinal direction of theattachment member or of the flexible elongated member.

The opening may have a width in a direction perpendicular to anextension of the flexible elongated member that substantiallycorresponds to a width of the flexible elongated member at a distancefrom the opening. In other words, the fixation assembly may have alarger width in a region of the one or more openings compared to a widthof the flexible elongated member along most of its extension. In asimilar manner, the thickness of the fixation assembly may be larger ina region of the one or more openings compared to a thickness of theflexible elongated member at a distance therefrom.

The attachment member may include multiple openings for receiving bonefasteners. The attachment member may have an opening for receiving abone fastener substantially perpendicular to bone. In oneimplementation, the attachment member may include a hole for receiving abone fastener substantially perpendicular to bone and arrangedsubstantially aligned with an oblong hole along a longitudinal directionof the attachment member or, alternatively, along a line substantiallyperpendicular to a longitudinal direction of the attachment member.Alternatively, or in addition, a hole having a locking feature forengaging a threaded head of a bone fastener at a selected angularorientation may be arranged on the attachment member substantiallyaligned with an elongated hole along a longitudinal direction of theattachment member or along a line which is substantially perpendicularto a longitudinal direction of the attachment member.

The attachment member may comprise an alternate arrangement of holes(locking holes) having a locking feature for locking a bone fastener tothe attachment member and elongated (or oblong) holes. For example, thefirst and third holes of a first section of the attachment member andthe second and fourth holes of a second section of the attachment membermay be elongated holes and/or the second and fourth holes of the firstsection of the attachment member and the first and the second holes ofthe second section of the attachment member may be holes having alocking feature for locking a bone fastener to the attachment member.Alternatively, or in addition, the locking holes may receive a bonefastener substantially perpendicular to bone.

The at least one opening of the attachment member may have a centralaxis which is oblique relative a vertical axis of the attachment member,e.g. of an extension plane thereof. An angle defined between the centralaxis and the vertical axis can be approximately between 0° and 60°.Alternatively, the at least one opening of the attachment member may beoblique relative to an upper surface (e.g., a side opposite a bonecontacting side) or lower surface (e.g., a bone contacting side) of theattachment member.

In one realization, the attachment member may be configured to be cutwith a surgical tool. The attachment member may define at least onecutting line or cutting edge. Thus, the attachment member can be adaptedin its shape and dimensions. Further, the number of openings of theattachment member can be adapted by cutting or trimming the attachmentmember. The surgical tool may be a cutting device, e.g., a plier orsurgical scissor.

In one implementation, each of the flexible elongated member and theattachment member may define a width in a transverse direction thereof.The width of the attachment member may be larger than a substantiallyequal to the width of the flexible elongated member. Each of theflexible elongated member and the attachment member may have athickness. The thickness of the attachment member may be larger than asubstantially equal to the thickness of a flexible elongated member.

A longitudinal orientation (or longitudinal direction) of the attachmentmember can be substantial along a longitudinal direction of the flexibleelongated member or can be substantially perpendicular thereto. Theattachment member may have an undulating outer contour. Thus, an outerperipheral surface of the attachment member may have an undulatingshape, such that the attachment member can have a waisted shape.Alternatively, or in addition, the attachment member may have a straightouter contour. Further, in one realization, the attachment member mayhave at least one extension element or arm extending from a central bodyof the attachment member. For example, the attachment member may havetwo, three or four arms extending therefrom.

In one implementation, the locking structure of the flexible elongatedmember may be arranged at or near one end of the flexible elongatedmember. The locking structure of the flexible elongated member mayinclude a latching mechanism configured to lock the flexible elongatedmember in a loop configuration.

Further, the flexible elongated member can include teeth, barbs or clawsarranged along a longitudinal direction of the flexible elongated memberand lockable with the latching mechanism. The teeth, barbs or claws maybe arranged on a side opposite a bone contacting side of the flexibleelongated member. Alternatively, or in addition, the teeth, barbs orclaws can be arranged on one or more lateral surfaces of the flexibleelongated member.

Alternatively or, in addition, the flexible elongated member may includeat least one opening or slot which is configured to engage at thelocking structure of the flexible elongated member (i.e., which arelockable with the latching mechanism). Thus, the flexible elongatedmember may include at least one opening or slot which is lockable withthe latching mechanism. The flexible elongated member may include aplurality of such openings or slots. The openings or slots may bearranged along a longitudinal direction of the flexible elongatedmember. The openings or slots may be arranged at a main (middle) portionor an end portion of the flexible elongated member. In oneimplementation, the openings or slots can be arranged at an end portionopposite or proximate the end having the locking structure of theflexible elongated member.

The latching mechanism can include at least one pawl, serration or lip,which is configured to engage the teeth, barbs or claws of the flexibleelongated member such that, once snapped in place, the correspondingtooth, barb claw will not be able to back out. Alternatively or, inaddition, the latching mechanism may include at least one pawl,serration or lip which is configured to engage on the at least oneopening or slot of the flexible elongated member such that, once snappedin place, the corresponding opening or slot will not be able to backout.

Further, the latching mechanism may include a through opening configuredto receive a part of the flexible elongated member. An inner surface ofthe through opening of the latching mechanism can include the at leastone pawl, serration or lip.

In one realization, the flexible elongated member may include a needleor a hook at an end thereof. The needle or hook may substantially berigid (e.g., in comparison to the flexible elongated member). Thelocking structure of the flexible elongated member can be arranged at anend of the flexible elongated member opposite to the end at which theneedle or hook is arranged. The needle or hook may therefore be arrangedat one end of the flexible elongated member and the locking structuremay be arranged proximate at the other end of the flexible elongatedmember. Furthermore, the end of the flexible elongated member includinga needle or hook is configured to be inserted through the throughopening of the latching mechanism.

The needle or hook may define a width in a transverse direction thereof.The width of the needle or hook may be smaller than a width of theflexible elongated member. Alternatively, the width of the needle orhook can be substantially equal to the width of the flexible elongatedmember. Further, the needle or hook may have a thickness. The thicknessof the needle or hook may be smaller than a thickness of the flexibleelongated member. Alternatively, the thickness of the needle or hook canbe substantially equal to the thickness of the flexible elongatedmember. The needle or hook may have a pointed end, a sharp end, a tipend or a blunt end.

The flexible elongated member may have a predetermined breaking line orperforation or, alternatively, a predetermined cutting line orperforation. The breaking or cutting line/perforation may be arrangednear one end of the flexible elongated member. Thus, the breaking orcutting line/perforation may be arranged near the needle or hook shapedend of the flexible elongated member.

The flexible elongated member and the attachment member may beintegrally formed. In other words, the flexible elongated member and theattachment member may be formed from one piece. Alternatively, theflexible elongated member and the attachment member can be separateparts from each other.

The flexible elongated member can be made from at least one of titanium,an alloy of titanium, stainless steel, polyetheretherketone (PEEK) and aresorbable material. Further, the attachment member may be made from atleast one of titanium, an alloy of titanium, stainless steel,polyetheretherketone (PEEK) and a resorbable material.

The flexible elongated member or the attachment member can be made froma biocompatible material, for example, a biocompatible metal.

The flexible elongated member may be a band, cable, wire or cerclage.Alternatively, the flexible elongated member can be a strap or a ribbon.In one implementation, the flexible elongated member can be formed as azip tie.

The attachment member can be formed as a bone plate. Alternatively, theattachment member can be formed as a mash.

At least a part of the flexible elongated member or at least a part ofthe attachment member can be pre-formed. Thus, the flexible elongatedmember or the attachment member may have a shape that substantiallyconforms with the sternum. Alternatively, or in addition, at least apart of the flexible elongated member or at least a part of theattachment member may be pre-bent flexible. This flexibility may allowthe fixation assembly to flex about an axis in its extension plane.Alternatively, or in addition, a surface (e.g., a lower surface) of theflexible elongated member or of the attachment member may have a profilethat substantially conforms with the sternum. This profile may have aconcave appearance or shape. Furthermore, this profile or pre-formingmay be made generic or patient specific, for example by adapting theshape of the profile or the pre-form based on a computed tomographic(CT) scan of the sternum of a patient.

In one realization, the attachment member may include at least onebridge configured to be cut with a surgical tool. The surgical tool maybe a cutting device, a plier or surgical scissor.

The attachment member may include a first section configured to besecured to the sternum and a second section configured to be secured tothe sternum. Thus, the first section of the attachment member can besecured to a first sternum part and the second section of the attachmentmember can be secured to a second sternum part. Each of the firstsection and the second section may have at least one opening forreceiving a bone fastener. The at least one opening can be configured asgenerally described above or hereinafter.

The at least one bridge may be configured to connect the first andsecond section of the attachment member to each other. In oneimplementation, the attachment member may include multiple bridges. Atleast two bridges can be arranged parallel to each other.

According to a further aspect, there is provided a fixation system forsecuring parts of a sternum, comprising a fixation assembly as generallydescribed above and hereinafter and at least one bone fastener. The atleast one bone fastener may be a locking screw, a cortical screw, acompression screw or a bone peg. The at least one bone fastener may be abone screw with a threaded head for (e.g., monoaxial or polyaxial)engagement of the locking feature of the at least one opening of theattachment member at a desired angle. The system may further comprise asurgical tool for cutting the attachment member or the at least onebridge of the attachment member.

According to a further aspect, there is provided a fixation system forsecuring parts of a sternum, comprising a fixation assembly as generallydescribed above and hereinafter and a further attachment member.

In the above aspect, the further attachment member can be formed as abone plate. Alternatively, the further attachment member can be formedas a mesh.

The further attachment member may be configured and defined as theattachment member of the fixation assembly as generally described aboveand hereinafter.

The further attachment member can be made from at least one of titanium,an alloy of titanium, stainless steel, polyetheretherketone (PEEK) and aresorbable material.

Moreover, the further attachment member may include at least one openingfor receiving a bone fastener. The at least one opening of the furtherattachment member can include a locking feature configured to lock abone fastener to the further attachment member. The locking feature caninclude a threaded portion or one or more lips in a circumferentialdirection adapted to engage a bone fastener (e.g., a threaded headthereof). Further, the locking feature may engage a threaded head of abone fastener at a selected angular orientation. The at least oneopening of the further attachment member may have a multiple thread(e.g., a double thread). Moreover, the at least one opening of thefurther attachment member may comprise a threaded portion on a bonefacing side of the further attachment member and an unthreaded portionon a side opposite to the bone facing side.

In one implementation, the at least one opening of the furtherattachment member may have a conical, convex or spherical taper whichsubstantially tapers inwardly in a direction toward a bone facingsurface of the further attachment member.

The at least one opening of the further attachment member can be acircular or elongated hole. In one realization, the further attachmentmember may include multiple openings for receiving bone fasteners.

Moreover, the at least one opening of the further attachment member mayhave an inclined surface onto which a bone fastener is able to slide ina fastening or compression position. The at least one opening of thefurther attachment member may permit a bone fastener to slide laterallyor longitudinally with respect to the opening or the further attachmentmember. Moreover, at least one opening of the further attachment membermay define a predetermined direction for a bone fastener. The inclinedsurface may have a predetermined angle with respect to an extensionplane of the further attachment member. The predetermined angle can bebetween about 20 and 70 degrees, for example about 40 to 50 degrees(e.g., about 45 degrees).

The at least one opening of the further attachment member may have acentral axis which is oblique relative a vertical axis of the furtherattachment member, e.g. of an extension plane thereof. An angle definedbetween the central axis and the vertical axis can be approximatelybetween 0° and 60°. Alternatively, the at least one opening of thefurther attachment member may be oblique relative to an upper surface(e.g., a side opposite a bone facing side) or lower surface (e.g., abone facing side) of the further attachment member.

The further attachment member may be configured to be cut with asurgical tool, e.g., with a cutting device, a plier or surgical scissor.

In one implementation, the further attachment member may include areceiving structure configured to receive at least a part of thefixation assembly (e.g., a part of the flexible elongated member or apart of the attachment member). The receiving structure of the furtherattachment member can be arranged on a bone facing side of the furtherattachment member. Moreover, the receiving structure of the furtherattachment member may be a recess, an opening or a groove. The receivingstructure may extend substantially along a longitudinal axis of thefurther attachment member or substantially perpendicular thereto. Thus,the receiving structure may extend substantially in a direction of alongitudinal axis of the flexible elongated member. Further, thereceiving structure of the further attachment member may be arranged ata central portion of the further attachment member. The receivingstructure of the further attachment member may be configured to receivea surgical wire (e.g., a Kirschner wire, K-wire).

Alternatively, or in addition, the further attachment member may includeat least one recess configured to receive a surgical wire, such as aKirschner wire (K-wire). The at least one recess can be arranged on abone facing side of the further attachment member. Moreover, the atleast one recess may be formed as an opening or a groove. The recess canbe substantially O-, U- or V-shaped in cross-section. The at least onerecess for receiving a surgical wire may extend substantially along alongitudinal axis of the further attachment member or substantiallyperpendicular thereto. Thus, the recess may extend substantially in adirection of a longitudinal axis of the flexible elongated member.Further, the at least one recess for receiving a surgical wire may bearranged at a central (middle) portion or at an outer portion (e.g. atan arm or section extending from the central portion) of the furtherattachment member.

The further attachment member may include at least one bridge configuredto be cut with a surgical tool.

In one realization, the further attachment member can include a firstsection configured to be secured to the sternum, e.g., to a firststernum part, and a second section configured to be secured to thesternum, e.g., to a second sternum part. Each of the first section andthe second section of the further attachment member may have at leastone opening for receiving a bone fastener. The at least one opening ofthe first or second section may be configured and defined as the atleast one opening of the attachment member of the fixation assembly asgenerally described and defined above and hereinafter. The at least onebridge of the further attachment member can be configured to connect thefirst and second section to each other.

In one realization, the further attachment member may include multiplebridges. At least two bridges can be arranged parallel to each other. Inone implementation, the at least one bridge of the attachment member ofthe fixation assembly may substantially overlap with the at least onebridge of the further attachment member. Thus, the at least one bridgeof the attachment member of the fixation assembly and the at least onebridge of the further attachment member can be cut with a surgical toolwithin one single cutting step.

In the aspect described above, the fixation system may further compriseat least one bone fastener. The at least one bone fastener may beconfigured to fasten the further attachment member to the fixationassembly and/or to bone. The at least one bone fastener may be a bonescrew with a threaded head for (e.g., monoaxial or polyaxial) engagementof the locking feature of the at least one opening of the furtherattachment member and/or the locking feature of the at least one openingof the attachment member of the fixation assembly. Moreover, the atleast one bone fastener may be a locking screw, a cortical screw, acompression screw or a bone peg. The system may further comprise asurgical tool for cutting the further attachment member or the at leastone bridge of the further attachment member.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and other features, aspects and advantages of the presentdisclosure will become apparent from the following detailed descriptiontaken in conjunction with the accompanying drawings wherein:

FIG. 1 a is a top view of a fixation assembly according to a firstembodiment;

FIG. 1 b is a cross-sectional view of the fixation assembly shown inFIG. 1 a;

FIG. 2 a is a top view of a fixation assembly according a secondembodiment;

FIG. 2 b is a cross-sectional view of the fixation assembly shown inFIG. 2 a;

FIG. 3 a is a top view of a fixation assembly according to a thirdembodiment;

FIG. 3 b is a cross-sectional view of the fixation assembly shown inFIG. 3 a;

FIG. 4 a is a top view of a fixation assembly according a fourthembodiment;

FIG. 4 b is a cross-sectional view of the fixation assembly shown inFIG. 4 a;

FIG. 4 c is a top view of an insert embodiment;

FIG. 4 d is a cross-sectional view of the insert embodiment shown inFIG. 4 c;

FIG. 5 a is a top view of a fixation assembly according to a fifthembodiment;

FIG. 5 b is a detailed cross-sectional view of the fixation assemblyshown in FIG. 5 a;

FIG. 5 c is a detailed cross-sectional view of another embodiment of thefixation assembly shown in FIG. 5 a;

FIG. 5 d is a detailed cross-sectional view of another embodiment of thefixation assembly shown in FIG. 5 a;

FIG. 6 a is a top view of a fixation assembly according to a sixthembodiment;

FIG. 6 b is a cross-sectional view of the fixation assembly shown inFIG. 6 a;

FIG. 7 is a top view of a further attachment member embodiment;

FIG. 8 is a perspective view of a bone fastener embodiment;

FIG. 9 a is a top view of a fixation system embodiment having thefixation assembly shown in FIGS. 6 a and 6 b and the further attachmentmember embodiment shown in FIG. 7 ;

FIG. 9 b is a top view of the fixation system embodiment shown in FIG. 9a with bone fastener embodiments shown in FIG. 8 ;

FIG. 10 shows the fixation system embodiment of FIG. 9 b attached on asternum of a patient;

FIG. 11 is a cross-sectional view of an alternative locking screw holeembodiment;

FIG. 12 is a view of the bone fastener embodiment shown in FIG. 8inserted in the alternative locking screw hole embodiment of FIG. 11 ;and

FIG. 13 is a perspective view of an alternative hole embodiment.

DETAILED DESCRIPTION

In the following, embodiments of a fixation assembly and a fixationsystem for securing parts of a sternum will be described. The samereference numerals will be used to denote the same or similar structuralfeatures.

Referring to FIG. 1 a , there is shown a top view of a first embodimentof a fixation assembly 10 for securing parts of a sternum. The fixationassembly 10 comprises a flexible elongated member 12 and an attachmentmember 14. The flexible elongated member 12 includes a locking structure16 which is configured to secure the flexible elongated member 12 in aloop around the sternum parts. As shown in FIG. 1 a , the attachmentmember 14 is coupled to the flexible elongated member 12. In the presentembodiment, the flexible elongated member 12 and the attachment member14 are integrally formed.

The flexible elongated member 12 is, as shown in FIG. 1 a , a band,e.g., a strap or ribbon. Alternatively, the flexible elongated member 12can be a cable, wire or cerclage. Further, the flexible elongated member12 and the attachment member 14 are made from titanium. Alternatively,the flexible elongated member 12 and/or the attachment member 14 may bemade from an alloy of titanium, stainless steel, polyetheretherketone(PEEK) or a resorbable material. In the present embodiment, theattachment member 14 is formed as a bone plate. At least a part of theflexible elongated member 12 or the attachment member 14 can bepre-formed (not shown in FIG. 1 a ).

As can be seen in FIG. 1 a , the locking structure 16 of the flexibleelongated member 12 is arranged near one end of the flexible elongatedmember 12. In the present embodiment, the locking structure 16 of theflexible elongated member 12 is arranged at an end (in FIG. 1 a on theright side) of the flexible elongated member 12. The locking structure16 includes a latching mechanism which is configured to lock theflexible elongated member 12 in a loop configuration, e.g., in a looparound sternum parts. The latching mechanism includes a through opening18. The through opening 18 is configured to receive a part of theflexible elongated member 12. Further, the latching mechanism includesat least one, in the present embodiment a single one, pawl 20.Alternatively, the latching mechanism includes at least one serration orlip. As shown in FIG. 1 a , an inner surface of the through opening 18of the latching mechanism includes the pawl 20.

The flexible elongated member 12 further includes teeth 22.Alternatively, the flexible elongated member 12 includes barbs or claws.The teeth 22 of the flexible elongated member 12 are arranged along alongitudinal direction of the flexible elongated member 12 and arelockable with the latching mechanism. The teeth 22 are positioned on aside 24 opposite a bone contacting side 26 of the flexible elongatedmember 12. Thus, the teeth 22 of the flexible elongated member 12 do notinterfere or infringe surrounding tissue or bone.

The other end of the flexible elongated member 12 (on the left side inFIG. 1 a ) can be inserted through the through opening 18 of thelatching mechanism of the locking structure 17 which is arranged on theother, opposite end of the flexible elongated member 12. The pawl 20 ofthe latching mechanism is configured to engage the teeth 22 of theflexible elongated member 12. Thus, once the end of the flexibleelongated member 12 opposite to the locking structure 16 is insertedthrough the through opening 18 of the latching mechanism and the teeth22 are snapped in place by engaging on the pawl 20 of the lockingstructure 16, the corresponding tooth 22 will not be able to back out.Thus, in the present embodiment, the flexible elongated member 12 isformed as a zip tie.

As shown in FIG. 1 a , the end of the flexible elongated member 12 whichis insertable through the through opening 18 of the latching mechanism,e.g., the end of the flexible elongated member 12 opposite to thelocking structure 16, includes a needle 28. Alternatively, the flexibleelongated member 12 includes a hook at an end thereof. The needle shapedend 28 of the flexible elongated member 12 facilitates the implantationand insertion of the fixation assembly 10 on and around the sternum of apatient.

As can be seen in FIG. 1 a , each of the flexible elongated members 12and the attachment member 14 defines a width in a transverse directionthereof. The width of the attachment member 14 is, in the presentembodiment, larger than the width of flexible elongated member 12.Alternatively, the width of the attachment member 14 can besubstantially equal to the width of the flexible elongated member 12.Further, a longitudinal orientation of the attachment member 14 issubstantially along a longitudinal direction of the flexible elongatedmember 12. As shown in FIG. 1 a , the attachment member 14 has anundulating outer contour. In the present embodiment, an outer peripheralsurface of the attachment member 14 has an undulating shape, such thatthe attachment member 14 has a waisted shape. Thus, the attachmentmember 14 includes at least one bridge 30 which is defined by theundulating outer contour. The attachment member 14 is configured to becut with a surgical tool such as a plier or a cutting device. In thepresent embodiment, the attachment member 14 includes three bridges 30.Thus, the attachment member 14 includes multiple bridges 30. Each of thebridges 30 of the attachment member 14 is configured to be cut with asurgical tool. Further, each bridge 30 defines a cutting section orcutting line alone which a surgeon can cut the attachment member 14 withthe surgical tool.

Further, the attachment member 14 includes a first section 32 configuredto be secured to the sternum and a second section 34 configured to besecured to the sternum. The first section 32 can thus be secured to afirst sternum part and the second section can be secured to a secondsternum part, e.g., separated from the first sternum part. As shown inFIG. 1 a , one bridge 30 connects the first and the second section 32,34 to each other.

Further, at least two, in the present embodiment all, bridges 30 arearranged parallel to each other. As can be seen in FIG. 1 a , theattachment member 14 has at least one opening 36 for receiving a bonefastener (not shown in FIG. 1 a ). In the present embodiment, theattachment member 14 includes four openings 36. The attachment member 14thus includes multiple openings 36 for receiving bone fasteners. Theseopenings 36 are arranged substantially along a longitudinal direction ofthe attachment member 14. As shown in FIG. 1 a , each of the firstsection 32 and the second section 34 has at least one opening 36 forreceiving a bone fastener. In the present embodiment, the first section32 includes two openings 36 and the second section 34 includes also twoopenings 36 for receiving a bone fastener. The features of the opening36 of the attachment member 14 are described below with reference toFIG. 1 b.

Referring to FIG. 1 b , there is shown a cross-sectional side view ofthe first fixation assembly embodiment of FIG. 1 a . It can be seen inFIG. 1 b that each of the openings 36 of the attachment member 14 has aconical taper 38 which substantially tapers inwardly in a directiontowards the bone contacting surface 26 of the attachment member 14 in aconical fashion. Alternatively, the at least one opening 36 of theattachment member 14 has a convex or spherical taper, i.e., has a curvedshape. Further, each of the openings 36 of the attachment member 14 mayhave an inclined surface 38 onto which a bone fastener is able to slidein a fastening or compression position. The taper 38 may form acountersink. Moreover, the taper 38 may extend over the fullcircumference of the opening 36. Alternatively, the taper 38 may extendover an arc segment of the circumference of the opening 36. The taper 38or the inclined surface 38 may be configured to receive a curved-shapedhead of a bone fastener.

A cone angle of the taper 38 of each of the openings 36 of theattachment member 14 may generally be between 1 degree and 80 degrees,and is approximately 45 degrees in the present embodiment. Thus, eachopening 36 of the attachment member 14 is, on the one hand, adapted toslidingly receive bone fasteners (such as sliding or compressionscrews), and, on the other hand, adapted to receive a locking screw or acortical screw. In case of a locking screw, a threaded head thereofmates with the locking feature 40 of the opening 36 for providing anangularly stable locking engagement therebetween at a pre-defined angle(i.e., monoaxially).

As shown in FIGS. 1 a and 1 b , each opening 36 of the attachment member14 is formed as a circular hole. Alternatively, at least one opening 36of the attachment member 14 can be an elongated, e.g., an oblong hole.

In the present embodiment, each of the openings 36 of the attachmentmember 14 includes a locking feature 40. The locking feature 40 isconfigured to lock a bone fastener (not shown in FIGS. 1 a and 1 b ) tothe attachment member 14. The locking feature includes a threadedportion. In the present embodiment, the locking feature 40 of eachopening 36 of the attachment member 14 is formed as a thread, e.g., athreaded hole portion. Alternatively, or in addition, the lockingfeature 40 may be formed as one or more circumferential lips, as abayonet-type feature or otherwise. The threaded portion of the lockingfeature 40 is adapted to engage a bone fastener, e.g., engage a threadedhead of a bone fastener. Thus, each of the openings 36 of the attachmentmember 14 can have a circumferential thread or is partially threaded.

As shown in FIG. 1 b , each of the openings 36 includes an upper portionand a lower portion. The upper portion of each opening 36 is on the side24 opposite to the bone contacting side 26. The lower portion of eachopening 36 is at the bone contacting side 26. As can be seen in FIG. 1 b, the upper portion defines taper 38. The lower portion includes thelocking feature 40 in form of a thread to engage a bone fastener.

Each of the flexible elongated member 12 and the attachment member 14has a thickness as shown in FIG. 1 b . The thickness of the attachmentmember 14 is, in the present embodiment, substantially equal to thethickness of the flexible elongated member 12. Alternatively, thethickness of the attachment member 14 is larger than the thickness ofthe flexible elongated member 12.

The locking structure 16 of the flexible elongated member 12 has athickness greater than the thickness of the flexible elongated member12. Further, the locking structure 16 extends from the bone contactingside 26 away from the flexible elongated member 12. The pawl 20 isarranged within the locking structure 16 and extends from the innersurface of the through opening 18 of the latching mechanism inwardlyinto the through opening 18 as shown in FIG. 1 b . As shown, the pawl 20extends in a direction toward the flexible elongated member 12.

The teeth 22 of the flexible elongated member 12 are arranged on side 24opposite to the bone contacting side 26. Further, the teeth 22 extendsubstantially away from the side 24 of the flexible elongated member 12in a direction substantially toward the locking structure 16. Thus, eachtooth 22 defines an angle with respect to the (upper) side 24 of theflexible elongated member 12. This angle can be between 1 degree and 90degrees, and is preferably substantially 45 degrees. Therefore, eachtooth 22 can interlock with the pawl 20 of the locking structure 16 tohold the fixation assembly around the sternum in a closed loop.

Referring to FIGS. 2 a and 2 b , there is shown a second embodiment of afixation assembly 42 for securing parts of a sternum.

FIG. 2 a illustrates a top view of the fixation assembly 42 and FIG. 2 billustrates a cross-sectional side view of the fixation assembly 42. Thefixation assembly 42 includes the flexible elongated member 12 and theattachment member 14 and their configurations as described withreference to and as shown in FIGS. 1 a and 1 b . The only differencebetween the fixation assembly 10 shown in FIGS. 1 a and 1 b and thefixation assembly 42 of the present embodiment is the arrangement andthe position respectively of the pawl 20 of the locking structure 16 andof the teeth 22 of the flexible elongated member 12.

In the present embodiment, the teeth 22 are arranged on a lateralsurfaces, i.e., the side surfaces, of the flexible elongated member 12as shown in FIG. 2 a . Alternatively, the teeth 22 can only be arrangedon one lateral surface of the flexible elongated member 12. Further, twopawls 16 are provided within the through opening 18 of the latchingmechanism to engage on teeth 22 once they are snapped in place. As shownin FIG. 2 a , the two pawls 16 facing each other are arranged onopposite sides of the locking structure 16. Alternatively, only one pawl16 may be provided within the through opening 18 of the latchingmechanism. In this case, the pawl 16 is arranged on that lateral surfaceor side of the locking structure 16 which corresponds to the lateralsurface or side of the flexible elongated member 12 on which the teeth22 are arranged.

Referring to FIGS. 3 a and 3 b , there is shown a third embodiment of afixation assembly 44 for securing parts of a sternum. FIG. 3 a shows atop view of the fixation assembly 44 and FIG. 3 b shows across-sectional side view of the fixation assembly 44.

The fixation assembly 44 includes the flexible elongated member 12 andthe attachment member 14 and their configurations as described withreference to and as shown in FIGS. 1 a and 1 b . The only differencebetween fixation assembly 10 shown in FIGS. 1 a and 1 b and the fixationassembly 44 of the present embodiment is that the attachment member 14has a longitudinal orientation which is substantially perpendicular to alongitudinal direction of the flexible elongated member 12. Further, theattachment member 14 of the fixation assembly 44 has multiple openings36.

In the present embodiment, the attachment member 14 has multiplecircular and elongated holes 36, e.g., four circular holes and fourelongated holes. Each circular hole 36 includes a locking feature 40 anda taper 38 and is configured as generally described above with referenceto and as shown in FIGS. 1 a and 1 b . Each elongated hole 36 may havean inclined surface onto which a bone fastener is able to slide in afastening or compression position. As shown in FIG. 3 a , each elongatedhole 36 extends substantial parallel with respect to a longitudinaldirection of the flexible elongated member 12. Thus, each of theelongated holes 36 of the attachment member 14 substantially extendsalong a line substantially perpendicular to a longitudinal direction ofthe attachment member 14. As can be further seen in FIG. 3 a , eachcircular hole 36 (e.g., for receiving a bone fastener substantiallyperpendicular to bone of the attachment member 14) is arrangedsubstantially aligned with an elongated hole 36 along the longitudinaldirection of the flexible elongated member 12 or, respectively, along aline substantially perpendicular to a longitudinal direction of theattachment member 14. Alternatively, or in addition, each circular hole36 having a locking feature 40 is arranged substantially aligned with anelongated hole 36 along the longitudinal direction of the attachmentmember 14. Thus, the attachment member 14 comprises an alternatearrangement of circular holes 36 having a locking feature 40 andelongated holes 36 for receiving, e.g., a compression screw.

As shown in FIG. 3 a , the first and third hole of the first section 32of the attachment member 14 and the second and fourth hole of the secondsection 34 of the attachment member 14 are elongated holes 36. Thesecond and fourth hole of the first section 32 of the attachment member14 and the first and the second hole of the second section 34 of theattachment member 14 are circular holes 36 having a locking feature 40(e.g., for receiving a bone fastener substantially perpendicular tobone).

The attachment member 14 further includes in a central portion thereof arecess 46. The recess 46 has a substantially rectangular form.Alternatively, the recess 46 may have a circular or triangular form.Further, the recess 46 is used as a window for aligning the fixationassembly 42 correctly on the sternum by allowing a surgeon to viewthrough the recess 46. Thus, the cutting line of the two sternum partscan be seen through recess 46 of the attachment member 14 which is thenprobably aligned on the two sternum parts.

Referring to FIGS. 4 a to 4 d , there is shown a fourth embodiment of afixation assembly 48 for securing parts of a sternum.

FIG. 4 a shows a top view of the fixation assembly 48 and FIG. 4 b showsa cross-sectional side view of the fixation assembly 48. Further, FIG. 4c shows a top view of an embodiment of the attachment member 14 and FIG.4 d shows a cross-sectional side view of thereof.

The fixation assembly 48 of the present embodiment includes the flexibleelongated member 12 as configured and described with reference to and asshown in FIGS. 1 a and 1 b . The difference between the flexibleelongated member shown in FIG. 1 a and that of the present embodiment isthat the flexible elongated member 12 has a receiving structure 50. Thereceiving structure 50 is configured to receive the attachment member14. A further difference is that the attachment member 14 is formed asan insert. Thus, the attachment member 14 of the present embodiment is aseparate part. The insert 14 can be inserted into the receivingstructure 50. The attachment member 14 in form of an insert is shown inFIGS. 4 c and 4 d and is substantially configured and defined asgenerally described with reference to and as shown in FIGS. 1 a and 1 b.

As shown in FIGS. 4 a and 4 b , the receiving structure 50 includes atleast one opening 52. In the present embodiment, the receiving structure50 includes four openings 52 which are aligned along a longitudinaldirection of the receiving structure 50. The shapes of the openings 52of the receiving structure 50 are adapted to receive the attachmentmember 14 in a suitable manner. The receiving structure 50 may thus havean inner shape which substantially corresponds (i.e., mates with) theouter shape of the attachment member 14.

The attachment member 14 as shown in FIGS. 4 c and 4 d includes theopenings 36 as described above with reference to FIGS. 1 a and 1 b .However, in the present embodiment, each opening 36 of the attachmentmember 14 is a circular hole. Further, each opening 36 has an uppercylindrical portion and a lower cylindrical portion as shown in FIG. 4 d. The lower cylindrical portion includes the locking feature 40.

The attachment member 14 is, in the present embodiment, held in thereceiving structure 50 by a from fit. The receiving structure 50 isconfigured to establish the holding of the attachment member 14 by asnap fit. This may be accomplished with a flexible or elatiscalprotrusion (not shown in FIGS. 4 a and 4 b ) of the receiving structure50. Alternatively, the attachment member 14 is cast in the flexibleelongated member 12.

Once the attachment member 14 in form of the insert is inserted in thereceiving structure 50 of the flexible elongated member 12, the openings52 of the receiving structure 50 substantially overlap with the openings36 of the attachment member 14. Thus, a bone fastener can be insertedthrough the openings 36 of the attachment member 14 into bone.

As can be seen in FIG. 4 b , the receiving structure 50 (or at least apart thereof) has a thickness which is substantially equal to athickness of the flexible elongated member 12. Alternatively, at least apart of the receiving structure 50 or the entire receiving structure 50has a thickness which is larger than a thickness of the flexibleelongated member 12.

FIG. 5 a shows a fifth embodiment of a fixation assembly 54 for securingparts of a sternum.

FIG. 5 a illustrates a top view of a fixation assembly 54 having adetailed cross-sectional view of a part of the attachment member 14. Thefixation assembly 54 comprises the flexible elongated member 12 asgenerally described with reference to as shown in FIGS. 1 a and 1 b .Further, the fixation assembly 54 includes the attachment member 14 asgenerally described with reference to and as shown in FIGS. 1 a and 1 bas well as FIGS. 3 a and 3 b.

In the present embodiment, the attachment member 14 includes multipleopenings 36 for receiving bone fasteners. As shown in FIG. 5 a , eightcircular holes 36 each having a locking feature 40 in form of a threadare provided in attachment member 14. The attachment member 14 is alsoconfigured to be cut with a surgical tool such as a plier or cuttingdevice. Thus, the number of openings 36 of the attachment member 14 canbe adapted by cutting or trimming the attachment member 14 as generallydescribed with reference to FIGS. 1 a and 1 b.

As shown in FIG. 5 a , the attachment member 14 has multiple arms 56, inthe present embodiment, four arms 56. The arms 56 of the attachmentmember 14 extend away from a central body of the attachment member 14.Further, the arms 56 have an undulating outer contour and include atleast one opening 36 (here, two openings 36) for receiving bonefasteners. Thus, an outer peripheral surface of the arms 56 has anundulating shape, such that the arms 56 have a waisted shape. Theattachment member 14 shown in FIG. 5 a has a similar shape andconfiguration as the attachment member shown in FIG. 3 a.

The difference between the attachment member 14 of the presentembodiment shown in FIG. 5 a and that shown and described with referenceto FIGS. 1 a and 3 a is that the attachment member 14 is slideablycoupled to the flexible elongated member 12. Thus, the attachment member14 of the present embodiment is a separate part. For this purpose, theattachment member 14 includes a guiding structure 58 for slideablyengaging the flexible elongated member 12. As shown in FIG. 5 a , theguiding structure 58 is substantially oriented along a line which issubstantially perpendicular to the longitudinal direction of theattachment member 14. Thus, the guiding structure 58 extendssubstantially along the longitudinal axis of the flexible elongatedmember 12. The guiding structure 58 receives the flexible elongatedmember 12 in a slideable manner. The attachment member 14 can thus slidealong the flexible elongated member 12 in the direction of thelongitudinal axis of the flexible elongated member 12. Hence, duringimplantation of the fixation assembly 54, the attachment member 14 canbe exactly aligned on the two parts of the sternum by sliding theattachment member 14 on the flexible elongated member 12.

The guiding structure 58 of the attachment member 14 may have differentforms, e.g., as shown in FIGS. 5 b, 5 c and 5 d . The guiding structure58 of the attachment member 14 is formed as a recess 60 or an opening60.

In the embodiment shown in FIG. 5 b , the recess 60 is formed as agroove 60. The groove 60 of the guiding structure 58 can receive theflexible elongated member 12, e.g. the flat band thereof, such that theattachment member 14 can slide along the surface of the flexibleelongated member 12. Further, the groove 60 of the guiding structure 58has a stepped configuration as shown in FIG. 5 b . The groove 60 thushas two (or more) different lateral dimensions. As can be seen in FIG. 5b , the groove 60 includes an upper groove section having a smallerwidth and a lower groove section having a larger width. Each of thesegroove sections may receive a flexible elongated member 12.

FIG. 5 c shows another embodiment of the guiding structure 58. In thisembodiment, the guiding structure 58 also includes a recess 60. However,the recess 60 is here formed as a groove having a T-form incross-section. As shown in FIG. 5 c , two protrusions 62 of the guidingstructure 58 define the T-shaped grooved 60. Further these protrusions62 captively held the flexible elongated member 12 in a directionsubstantially perpendicular to the sliding direction of the attachmentmember 14 (i.e., to the longitudinal direction of the flexible elongatedmember 12).

FIG. 5 d illustrates a further embodiment of the guiding structure 58.In this embodiment, the recess 60 of the guiding structure 58 is formedas an opening 60, i.e., a through opening. The opening 60 of the guidingstructure 58 has in cross-section a form of an elongated or oblong hole.Further, the opening 60 of the guiding structure 58 extendssubstantially through the attachment member 14. The opening 60 may alsoreceive the flexible elongated member 12 in a slideable manner along thelongitudinal direction of the flexible elongated member 12.

FIGS. 6 a and 6 b show a sixth embodiment of a fixation assembly 64 forsecuring parts of a sternum.

FIG. 6 a illustrates a top view of the fixation assembly 64 and FIG. 6 billustrates a cross-sectional side view of the fixation assembly 64. Thefixation assembly 64 comprises the flexible elongated member 12 and theattachment member 14 as generally described with reference to and asshown in FIGS. 1 a and 1 b.

The difference between the fixation assembly 64 shown in FIG. 6 a andthe fixation assembly 10 as shown in FIG. 1 a is that the attachmentmember 14 is, in the present embodiment, formed as a mesh. The mesh isintegrally formed with the flexible elongated member 12. Alternatively,the mesh can also be a separate part (e.g., an insert) from the flexibleelongated member 12.

The attachment member 14 formed as a mesh includes at least one ormultiple openings 36 for receiving bone fasteners. In the presentembodiment, the attachment member 14 includes five openings 36. Theseopenings 36 of the attachment member 14 are substantially arranged alongthe longitudinal axis (direction) of the attachment member 14. Further,each of the opening 36 includes a locking feature 40 and a taper 38 asgenerally described above with reference to FIGS. 1 a and 1 b .Alternatively, at least one of these openings 36 may have a cortical orconvex taper (e.g., an inclined surface) onto which a bone fastener isable to slide in a compression position or fastening position. As shownin FIG. 6 a , the openings 36 of the attachment member 14 are allcircular holes. However, also elongated holes can be provided in themesh structure of the attachment member 14. Each of the openings 36 ofthe attachment member 14 is connected to another opening 36 via at leastone bridge 30. The bridges 30 can be straight or curved as shown in FIG.6 a . Thus, the attachment member 14 may have an undulating outer shape.In the present embodiment, an outer peripheral surface of the attachmentmember 14 has an undulating shape, such that the attachment member 14has a waisted shape. Alternatively, or in addition, the attachmentmember 14 may have a straight outer contour.

Each of the bridges 30 of the mesh of the attachment member 14 isconfigured to be cut with a surgical tool, such as a plier or a cuttingdevice. Further, each of the bridges 30 may also have the configurationas generally described above with reference to and as shown in FIGS. 1 aand 1 b . At least two bridges 30 are arranged parallel to each other asshown in FIG. 6 a . Further, two openings 36 arranged adjacent to eachother and two curved bridges 30 opposite to each other form a recess 66.The recess 66 has substantially the form of a barbell as shown in FIG. 6a.

FIG. 7 shows a top view of a further attachment member embodiment 68.The further attachment member 68 has substantially the configuration ofthe attachment member 14 as described above and hereinafter.

The further attachment member 68 is formed as a bone plate.Alternatively, the further attachment member 68 may be formed as a mesh,e.g., a mesh as generally described with reference to and as shown inFIG. 6 a . The further attachment member 68 is, in the presentembodiment, made from titanium. Alternatively, or in addition, thefurther attachment member 68 can be made from at least one of an alloyof titanium, stainless steel, polyetheretherketone (PEEK) and aresorbable material.

As can be seen from FIG. 7 , the further attachment member 68 includes afirst section 32 configured to be secured to the sternum and a secondsection 34 configured to be secured to the sternum as generallydescribed with reference to FIGS. 1 a, 1 b, 3 a and 3 b . Each of thefirst section 32 and the second section 34 of the further attachmentmember 68 has at least one opening 36 for receiving a bone fastener. Inthe present embodiment, the further attachment member 68 includesmultiple openings 36 for receiving bone fasteners. Each of the openings36 of the further attachment member 68 may be configured as generallydescribed with reference to and as shown in FIGS. 1 a and 1 b as well asFIGS. 3 a and 3 b.

Moreover, each of the openings 36 of the further attachment member 68has a conical, convex or spherical taper 38 which substantially tapersinwardly in a direction toward a bone facing surface of the furtherattachment member 68. The bone facing surface is a surface of thefurther attachment member 68 which faces toward bone. Thus, the bonefacing surface of the further attachment member 68 substantiallycorresponds to a bone contacting surface. Further, each of the openings36 of the further attachment member 68 may have an inclined surface(e.g., taper 38) onto which a bone fastener is able to slide in afastening or compression position. The taper 38 may form a countersink.Moreover, the taper 38 may extend over the full circumference of theopening 36. Alternatively, the taper 38 may extend over an arc segmentof the circumference of the opening 36. The taper 38 or the inclinedsurface 38 may be configured to receive a curved-shaped head of a bonefastener. As can be seen from FIG. 7 , each opening 36 of the furtherattachment member 68 is a circular hole. Alternatively, or in addition,at least one opening 36 may be an elongated hole.

In the present embodiment as shown in FIG. 7 , each opening 36 of thefurther attachment member 68 includes a locking feature 40 configured tolock a bone fastener to the further attachment member 68. The lockingfeature 40 of each opening 36 of the further attachment member 68 has aconfiguration as generally described with reference to and as shown inFIGS. 1 a and 1 b . Thus, in the present embodiment, the locking feature40 includes a threaded portion adapted to engage a bone fastener. Indetail, each opening 36 of the further attachment member 68 includes athreaded for matingly engaging a threaded head of a bone fastener.Alternatively, at least one of the openings 36 of the further attachmentmember 68 includes one or more circumferential lips adapted to engage abone fastener.

As shown in FIG. 7 , the further attachment member 68 includes at leastone bridge 30 which is configured to be cut with a surgical tool, suchas a plier or cutting device. In the present embodiment, the furtherattachment member 68 includes two bridges 30. Thus, the furtherattachment member 68 is configured to be cut with a surgical tool, e.g.,into two pieces, if it is necessary when a complication takes placeafter the implantation of the fixation assembly and the furtherattachment member 68. The further attachment member 68 includes multiplebridges 30. In the present embodiment, the further attachment member 68has two bridges 30. As shown in FIG. 7 , the two bridges 30 of thefurther attachment member 68 connect the first section 32 and the secondsection 34 to each other. Further, the two bridges 30 are arrangedparallel to each other.

As can be seen in FIG. 7 , the further attachment member 68 includes arecess 46 used as a window as generally described with reference to andas shown in FIG. 3 a . Thus, a surgeon can exactly align the furtherattachment member 68 on the sternum by viewing through this recess 46.The recess 46 of the further attachment member 68 has a substantiallyrectangular form. Alternatively, the recess 46 may have a triangular orcircular shaped form. As can be seen from FIG. 7 , the two bridges 30and the first and second sections 32, 34 of the further attachmentmember 68 define the recess 46.

The further attachment member 68 further includes a receiving structure(not shown in FIG. 7 ) configured to receive a part of a fixationassembly. The receiving structure of the further attachment member maythus receive part of the first elongated member 12 or the attachmentmember 14 of one of the fixation assemblies described above orhereinafter. The receiving structure of the further attachment member 68is arranged on the bone facing side of the further attachment member 68.The further attachment member 68 can therefore be placed on top of thefixation assembly. The receiving structure may be a groove or recess.Further, the receiving structure may substantially extend in a directionof the longitudinal direction of the flexible elongate member 12 or along a line with is substantially perpendicular to the longitudinaldirection of the further attachment member 68.

FIG. 8 shows an embodiment of a bone fastener 70. The bone fastener 70is in form of a bone screw having a head 72 and a shaft 74. The head 72of the bone fastener 70 has a thread. The thread of the head 72 of thebone fastener 70 is configured to engage a thread 40 of one of theopenings 36 of the attachment member 14. As can be seen in FIG. 8 , thehead 72 of the bone fastener 70 has a conical outer shape.Alternatively, the head 72 may have a curved, e.g. convex or spherical,outer shape.

The shaft 74 of the bone fastener 70 has a thread for engaging bone(e.g., a cancellous thread). In the present embodiment, the bonefastener 70 is formed as a locking screw. Alternatively, the bonefastener can be a cortical screw, a compression screw or a bone peg.

A fixation system for securing parts of a sternum may comprise afixation assembly as previously described with reference to FIGS. 1 a to6 b and at least one bone fastener 70 as generally described withreference to and as shown in FIG. 8 .

FIG. 9 a illustrates a top view of a fixation system 76 for securingparts of a sternum. The fixation system 76 comprises the fixationassembly 64 as generally described with reference to and as shown inFIGS. 6 a and 6 b . Alternatively, the fixation system 76 may includeany previously described fixation assembly, e.g., as shown in FIGS. 1 ato 5 a . Moreover, the fixation system 76 comprises the furtherattachment member 68 as described with reference to and as shown in FIG.7 .

As shown in FIG. 9 a , the further attachment member 68 is arranged ontop of the fixation assembly 64. In this case, the receiving structureof the further attachment member 68 receives a part of the fixationassembly 64 at the bone facing side of the further attachment member 68.Alternatively, when the further attachment member 68 may not includesuch a receiving structure, the further attachment member 68 is justplaced on top of the fixation assembly.

As can be seen from FIG. 9 a , two of the openings 36 of the furtherattachment member substantially overlap with two openings 36 of theattachment member 14 of the fixation assembly 64. In detail, one opening36 of the first section 32 of the further attachment member 68substantially coincides with one opening 36 of the first section 32 ofthe attachment member 14 of the fixation assembly 64. Further, oneopening 36 of the second section 34 of the further attachment member 68substantially coincides with one opening 36 of the second section 34 ofthe attachment member 14 of the fixation assembly 64. Moreover, each ofthe two bridges 30 of the further attachment member 68 substantiallyoverlaps with at least one bridge 30 of the attachment member 14 of thefixation assembly 64. Thus, the pair of bridges 30 of the attachmentmember 14 of the fixation assembly 64 and the further attachment member68 can be cut with a surgical tool within one single cutting step.

FIG. 9 b is a top view of the fixation system 76 as shown in FIG. 9 aincluding bone fasteners 70 as described with reference to and as shownin FIG. 8 . In the present embodiment, the bone fasteners 70 are lockingscrews as illustrated in FIG. 8 .

As can be seen from FIG. 9 b , each opening 32 of the further attachmentmember 68 can receive a bone fastener 70. The bone fasteners 70 whichare inserted through the two openings 36 of the further attachmentmember 68 which coincide with openings 36 of the attachment member 14 ofthe fixation assembly 64 are configured to fasten the further attachmentmember 68 to the fixation assembly 64. Further, since the bone fasteners70 are locking screws with a threaded head for engaging on the lockingfeature 40 of each opening 36 of the further attachment member 68, thebone fastener 70 can be locked to the further attachment member 68.

Alternatively, or in addition, the fixation system 76 may comprise asurgical tool for cutting the bridges 30, the further attachment member68 and/or the attachment member 14. The surgical tool can be a cuttingdevice, a plier or surgical scissor.

FIG. 10 shows the fixation assembly 76 shown in FIGS. 9 a and 9 b thathas been attached to a sternum 78 with bone fasteners 70.

The two sternum parts that had been separated by a bone cut have beenbrought back to their initial position and secured by the fixationassembly 64. The fixation assembly 64 is firstly looped around the twosternum parts. Then, the attachment member 14 is properly aligned on thetwo sternum parts. The fixation assembly 64 is then tightened byinserting the needle shaped end of the flexible elongated member 12through the through opening 18 of the locking structure 16 of thefixation assembly 64. Then, the fixation assembly 64 is fixed by lockingthe teeth 22 of the flexible elongated member 12 of the fixationassembly 64 to the locking structure 16 of the fixation assembly 64. Ifnecessary, the attachment member 14 of the fixation assembly 64 is fixedto the sternum parts by inserting bone fasteners 70 through the openings36 of the attachment member 14 of the fixation assembly 64.Alternatively, or in addition, the further attachment member 68 isplaced on top of the fixation assembly 64 as shown in FIG. 10 . Thefurther attachment member 68 is then locked to the fixation assembly 64and/or fixed to the sternum 78 by bone fasteners 70 inserted through theopenings 36 of the further attachment member 68. In this case, asillustrated in FIG. 10 , the first section 32 of the further attachmentmember 68 (and, optionally, of the attachment member 14 of the fixationassembly 64) is attached to one sternum part and the second section 34of the further attachment member 68 (and, optionally, of the attachmentmember 14 of the fixation assembly 64) is attached to the other sternumpart.

During a period of coughing, a force acting on sternum 78 in a lateraldirection thereof may be up to 1500 Newton (N). It is therefore desiredto maintain the initial secured relative orientation of the sternumparts, even when the sternum 78 is subjected to forces of thismagnitude.

The closed configuration of the fixation assembly prevents relativedisplacement of the sternum parts in the lateral direction of thesternum 78 due to the flexible elongated member 12 looped around thesternum parts and, if necessary, also due to the attachment member 14 ofthe fixation assembly and/or the further attachment member 68 fixed tothe sternum 78 by bone fasteners 70. The fixation assembly and thefurther attachment member hold the two sternum parts in an abuttingrelationship. By the provision of openings 36 configured as elongatedholes, inclined holes or holes having an inclined surface or taper ontowhich a bone fastener is able to slide in a fastening or compressionposition, the sternum parts can be additionally compressed in thelateral direction upon tightening the associated bone fasteners.

Referring to FIG. 11 , there is shown a further embodiment 80 of anopening 36 in form of a locking screw hole 36 for an attachment memberas discussed herein. The locking screw hole 36 includes a lowercylindrical hole portion 82 on the bone contacting side of theattachment member and an upper cylindrical hole portion 84 on the sideopposite to the bone contacting side. A middle portion 86 is arrangedbetween the upper and lower cylindrical hole portion 82, 84. The middleportion 86 includes a circumferential lip 88 having roughly thecross-sectional shape of a triangle. Thus, in this embodiment, thelocking feature 40 of the opening 36 is formed as a circumferential lip88. A bone fastener 70 (not shown in FIG. 11 ) can be polyaxiallyinserted through the locking screw hole 36, wherein the bone fastener 70lockingly engages the circumferential lip 88. As further illustrated inFIG. 11 , a diameter of the middle portion 86 is smaller than each of adiameter of the upper cylindrical portion 84 and a diameter of the lowercylindrical portion 82. Moreover, the locking screw hole 36 includes asupporting structure 90 defined by the upper cylindrical portion 84. Thesupporting structure 90 may receive a head portion of a bone fastener 70(not shown in FIG. 11 ).

FIG. 12 shows a view of the bone fastener embodiment 70 shown in FIG. 8inserted in the alternative locking screw hole embodiment 80 shown inFIG. 11 .

As can be seen in FIG. 12 , the bone fastener 70 can be inserted in thelocking screw hole 36 at different angles relative to a central axis 92of the locking screw hole 36. Thus, an insertion angle of the bonefastener 70 may vary from about 0 to about 45 degrees (e.g., from about0 to about 10 degrees) relative to the central axis 92 of the lockingscrew hole 36.

The thread of the head 72 of bone faster 70 is configured to engage onthe circumferential lip 88 which has roughly the cross-sectional shapeof a triangle. The bone fastener 70 can thus be polyaxially insertedthrough the locking screw hole 36, wherein the bone fastener 70lockingly engages the circumferential lip 88.

Referring to FIG. 13 there is shown is a perspective view of a furtherembodiment 94 of an opening 36 in form of a sliding screw hole 36 for anattachment member as discussed herein. In the present embodiment, thesliding screw hole 36 is formed as an elongated (e.g., oblong) hole.

The sliding screw hole 36 includes a lower cylindrical hole portion 82on the bone contacting side of the attachment member and an uppercylindrical hole portion 84 on the side opposite to the bone contactingside. In the present embodiment, the upper cylindrical hole portion 84extends over an arc segment of the circumference of the sliding screwhole 36 as shown in FIG. 13 . The upper cylindrical hole portion 84 mayextend over about 160 to about 260 degrees (e.g. about 160 to about 200degrees), and in the present embodiment about 180 degrees.

The lower cylindrical hole portion 82 may include the locking feature 40as generally described above. Thus, the lower cylindrical hole portion82 may have a thread 40 or circumferential lip 88 configured to engageon a thread head 72 of a bone fastener 70 (not shown in FIG. 13 ).

A middle portion 86 is arranged between the upper and lower cylindricalhole portion 82, 84. The middle portion 86 includes a taper whichsubstantially tapers inwardly in a direction toward a bone contactingsurface of the attachment member in a conical fashion. In the presentembodiment, the middle portion 86 also extends over an arc segment ofthe circumference of the sliding screw hole 36 as shown in FIG. 13 . Themiddle portion 86 may extend over about 160 to about 260 degrees, e.g.about 160 to about 200 degrees, and in the present embodiment about 180degrees. The middle portion 86 may also include the locking feature 40as generally described above. Thus, the middle portion 86 may have athread 40 or circumferential lip 88 configured to engage on a threadhead 72 of a bone fastener 70 (not shown in FIG. 13 ).

The sliding screw hole 36 further includes an inclined surface 38 ontowhich a bone fastener 70 is able to slide in a fastening or compressionposition. Thus, the sliding screw hole 36 may permit a bone fastener 70to slide laterally or longitudinally with respect to the sliding screwhole 36. Further, the sliding screw hole 36 may define a predetermineddirection for a bone fastener 70. The inclined surface 38 has apredetermined angle with respect to an extension plane of the attachmentmember or with respect to the central axis of the sliding screw hole 36.The predetermined angle can be between about 20 and 70 degrees, forexample about 40 to 50 degrees, and is, in the present embodiment, about45 degrees. Moreover, the inclined surface 38 extends over an arcsegment of the circumference of the sliding screw hole 36.Alternatively, the inclined surface 38 may extend over the fullcircumference of the sliding screw hole 36. The sliding screw hole 36may include two or more inclined surfaces 38 onto which a bone fastener70 is able to slide in a fastening or compression position. One inclinedsurface 38 may be arranged within sliding screw hole 36 opposite afurther inclined surface 38. Thus, two inclined surfaces 38 may bearranged facing each other. The inclined surface 38 is configured toreceive a curved or conical shaped head of a bone fastener 70. The bonefastener 70 may be a sliding screw, e.g., a compression screw.

Thus, a bone fastener 70 is able to slide (e.g., laterally orlongitudinally) on the inclined surface 38 in a fastening or compressionposition. The sliding screw hole 36 is thus configured to exert a forceon the attachment member when a bone fastener 70 is screwed or insertedthrough the sliding screw hole 36 into the sternum. Once, a bonefastener 70 in form of a locking screw inserted through the slidingscrew hole 36 has reached a fastening position, the threaded head 72 oflocking screw 70 lockingly engages the locking feature 40 (e.g., athread or circumferential lip) of the lower cylindrical hole portion 82of the sliding screw hole 36. Alternatively, when a bone fastener 70 inform of a sliding or compression screw inserted through the slidingscrew hole 36 has reached a compression position, the conical or curvedhead of bone fastener 70 abuts against the taper of the middle portion86 of the sliding screw hole 36.

As described above, each of the first and second section 32, 34 of theattachment member 14 or the further attachment member 68 may include anopening 36 for receiving a bone fastener (e.g., a sliding screw hole 36as described above with reference to and as shown in FIG. 13 ). Thus, atleast one sliding screw hole 36 may be arranged in the first section 32and at least one sliding screw hole 36 may be arranged in the secondsection 34 of the attachment member 14, 68. The sliding screw holes 36of the first and second section 32, 34 may be arranged opposite to eachother. Further, the sliding screw holes 36 of the first and secondsection 32, 34 may be facing each other. The inclined surfaces 36 of thesliding screw holes 36 of the first and second section 32, 34 may extendsubstantially in a direction of the longitudinal axis of the attachmentmember 14, 68 or substantially perpendicular thereto. Hence, theinclined surfaces 36 may substantially extend towards a cutting line ofthe sternum halves.

In one implementation, the sliding screw holes 36 of the first andsecond section 32, 34 may be arranged mirror-inverted with respect to amirror axis. The mirror axis can be defined by the longitudinal axis ofthe attachment member 14, 68 or a line substantially perpendicularthereto. Thus, the mirror axis may extend substantially along a cuttingline of the sternum halves.

Consequently, a bone fastener 70 is able to slide on the inclinedsurface 38 of one of the sliding screw hole 36 substantially in adirection towards the cutting line of the sternum halves in a fasteningor compression position. Thereby, the sternum halves are compressed toeach other. The sliding screw hole 36 is thus configured to exert aforce on the attachment member and therewith on the two sternum halveswhen a bone fastener 70 is screwed or inserted through the sliding screwhole 36 into the sternum.

The flexible elongated member 12 and attachment member 14 of thefixation assemblies and/or the further attachment member as describedabove, can be adapted to different sternum applications and may thushave different holes and a different shape. Thus, the flexible elongatedmember and the attachment members can be adapted as needed (e.g., interms of shape, length, width, thickness, etc.) for use in orthopedicsurgery for fixation of sternum bone, in particular, for securing atleast two parts of a sternum together. Further, while many of theopenings shown herein are circular, they could be elongated as well.

While the bone fasteners as described and shown herein are formed aslocking screws, the bone fasteners can be of any type (e.g., corticalscrews, compression screws, sliding screws, bone pegs, guide bushings,any kind of blade or wire-like fasteners) and can be adapted todifferent applications as needed. The bone fasteners may thus havedifferent diameters, length, shapes or threads. Further, the fastenersand the implants described above can generally be made of stainlesssteel, titanium or any other biocompatible material.

While the above embodiments have exemplary been described in relation tobone screws, bone plates and meshes, it will be readily apparent thatthe techniques presented herein can also be implemented in combinationwith other types of bone fasteners (such as bone pegs having a rod-likeor pin-like shaft, wire-like bone fasteners, etc.) as well as othertypes of implants (such as nails, bone distractors, etc.). Accordingly,the present disclosure is not limited to any type of bone fastener orany type of implant.

The features described in the above description taken in conjunctionwith the accompanying drawings can be readily combined to result indifferent embodiments. It will thus be apparent that the presentdisclosure may be varied in many ways. Hence, any described features maybe used in all possible combinations. Such variations are not to beregarded as a departure from the scope of the disclosure, and allmodifications are intended to be included within the scope of thefollowing claims.

The invention claimed is:
 1. A fixation assembly for securing parts of asternum, the assembly comprising: a flexible elongated member includinga locking structure configured to secure the flexible elongated memberin a loop around the sternum parts; and an attachment member having atleast one opening for receiving a bone fastener, wherein the attachmentmember is coupled to the flexible elongated member, wherein theattachment member is cast in the flexible elongated member.
 2. Thefixation assembly according to claim 1, wherein the flexible elongatedmember and the attachment member are integrally formed.
 3. The fixationassembly according to claim 1, wherein the flexible elongated member ismade from at least one of titanium, an alloy of titanium, stainlesssteel, polyetheretherketone (PEEK) and a resorbable material, and theattachment member is made from at least one of titanium, an alloy oftitanium, stainless steel, polyetheretherketone (PEEK) and a resorbablematerial.
 4. The fixation assembly according to claim 1, wherein each ofthe flexible elongated member and the attachment member defines a widthin a transverse direction thereof, wherein the width of the attachmentmember is larger than or substantially equal to the width of theflexible elongated member.
 5. The fixation assembly according to claim1, wherein each of the flexible elongated member and the attachmentmember has a thickness, wherein the thickness of the attachment memberis larger than or substantially equal to the thickness of the flexibleelongated member.
 6. The fixation assembly according to claim 1, whereina longitudinal orientation of the attachment member is substantiallyperpendicular to a longitudinal direction of the flexible elongatedmember.
 7. The fixation assembly according to claim 1, wherein thelocking structure of the flexible elongated member is arranged at ornear one end of the flexible elongated member.
 8. The fixation assemblyaccording to claim 1, wherein the locking structure of the flexibleelongated member includes a latching mechanism configured to lock theflexible elongated member in a loop configuration.
 9. The fixationassembly according to claim 8, wherein the flexible elongated memberincludes teeth, barbs or claws arranged along a longitudinal directionof the flexible elongated member and lockable with the latchingmechanism.
 10. The fixation member according to claim 1, wherein theattachment member includes: a first attachment section having at leastone opening for receiving a bone fastener and being configured to besecured to the sternum; and a second attachment section having at leastone opening for receiving a bone fastener and being configured to besecured to the sternum.
 11. The fixation assembly according to claim 10,wherein the attachment member includes at least one bridge configured toconnect the first attachment section and second attachment section toeach other and configured to be cut with a surgical tool.
 12. Thefixation assembly according to claim 11, wherein the attachment memberincludes multiple bridges.
 13. The fixation assembly according to claim12, wherein the bridges of the attachment member and the flexibleelongated member jointly define a cutting line.
 14. The fixationassembly according to claim 13, wherein the cutting line extendssubstantially along the longitudinal axis of the attachment member. 15.The fixation assembly according to claim 11, wherein the attachmentmember incudes at least two bridges that are arranged parallel to eachother.
 16. The fixation assembly according to claim 10, wherein thefirst attachment section and the second attachment section are arrangedon opposite lateral sides of the flexible elongated member.
 17. Thefixation assembly according to claim 10, wherein each of the firstattachment section and the second attachment section has at least fouropenings for receiving a bone fastener.
 18. The fixation assemblyaccording to claim 10, wherein the first attachment section and thesecond attachment section are integrally formed with the flexibleelongated member.
 19. A fixation assembly for securing parts of asternum, the assembly comprising: a flexible elongated member includinga locking structure configured to secure the flexible elongated memberin a loop around the sternum parts; and an attachment member coupled tothe flexible elongated member, wherein the attachment member includes: afirst attachment section comprising at least one opening for receiving abone fastener; a second attachment section comprising at least oneopening for receiving a bone fastener; and bridges configured to connectthe first and second attachment section to each other and to be cut witha surgical tool, wherein the attachment member is cast in the flexibleelongated member.
 20. A fixation assembly for securing parts of asternum, the assembly comprising: a flexible elongated member includinga locking structure configured to secure the flexible elongated memberin a loop around the sternum parts; and an attachment member having atleast one opening for receiving a bone fastener, wherein the attachmentmember is coupled to the flexible elongated member, wherein theattachment member includes: a first attachment section configured to besecured to the sternum; a second attachment section configured to besecured to the sternum; and multiple bridges configured to connect thefirst and second attachment section to each other and configured to becut with a surgical tool; wherein the bridges of the attachment memberand the flexible elongated member jointly define a cutting line, andwherein the attachment member is cast in the flexible elongated member.